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Diagnostic Test
DNA Methylation Testing for Thyroid Nodules
N/A
Recruiting
Led By John H Yim
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients without impaired decision-making capacity and who are undergoing needle biopsies for thyroid nodule diagnosis
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is testing a new way to test for thyroid cancer using needle biopsies. The goal is to develop a more accurate test to avoid unnecessary surgeries for benign thyroid nodules.
Who is the study for?
This trial is for adults with thyroid nodules who are undergoing needle biopsies. Participants must be able to give informed consent and have the capacity to make decisions about their healthcare. Children are excluded because the biology of their thyroid nodules differs from that of adults.Check my eligibility
What is being tested?
The study is testing a new diagnostic method using DNA methylation signatures from needle biopsy samples to distinguish between malignant (cancerous) and benign (non-cancerous) thyroid tumors, aiming to reduce unnecessary surgeries.See study design
What are the potential side effects?
Since this trial involves reviewing electronic health records and performing standard diagnostic procedures like needle biopsies, side effects may include discomfort or bruising at the biopsy site, bleeding, infection risk, and very rarely damage to nearby structures.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am mentally capable and scheduled for a thyroid biopsy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Negative predictive value (NPV) of DDMS-2
Positive predictive value (PPV) of DDMS-2
Sensitivity of Diagnostic Deoxyribonucleic Acid (DNA) Methylation Signatures (DDMS-2)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Diagnostic (needle biopsy, DDMS-2)Experimental Treatment3 Interventions
Patients undergo needle biopsy for collection of tissue samples. Tissue samples are analyzed using DDMS-2. Patients' medical records are also reviewed.
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,920,010 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,924,748 Total Patients Enrolled
John H YimPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.My gender, race, or ethnicity does not limit my participation.I am mentally capable and scheduled for a thyroid biopsy.I am an adult.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (needle biopsy, DDMS-2)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there vacancies within this research trial for participants?
"Clinicaltrials.gov states that this clinical trial is actively enrolling patients, with the protocol first posted on October 22nd 2021 and last modified on February 4th 2022."
Answered by AI
What is the participant count for this investigation?
"Affirmative. Clinicaltrials.gov documents that this medical trial is currently recruiting for 1 site with a total of 1450 patients since its posting on October 22nd 2021 and last update on February 4th 2022."
Answered by AI
Who else is applying?
What state do they live in?
Tennessee
How old are they?
18 - 65
What site did they apply to?
City of Hope Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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